Cleared Traditional

K103298 - ACAM 5 AUDIOMETER SYSTEM

K103298 is an FDA 510(k) clearance for ACAM 5 AUDIOMETER SYSTEM, manufactured by Acousticon GmbH. The device is a Class 2 Ear, Nose, Throat device with product code EWO cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K103298 · Acousticon GmbH · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
151d
Days
Class 2
Risk

K103298 is an FDA 510(k) clearance for the ACAM 5 AUDIOMETER SYSTEM. Classified as Audiometer (product code EWO), Class II - Special Controls.

Submitted by Acousticon GmbH (Toms River, US). The FDA issued a Cleared decision on April 8, 2011 after a review of 151 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1050 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Acousticon GmbH devices

FDA 510(k) Submission Details - K103298

510(k) Number K103298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2010
Decision Date April 08, 2011
Days to Decision 151 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 89d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EWO Device Classification - Class 2, Special Controls

Product Code EWO Audiometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EWO Audiometer

All 55
Devices cleared under the same product code (EWO) and FDA review panel - the closest regulatory comparables to K103298.
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